Effect of Head Rotation on Efficiency of Face Mask Ventilation in Anesthetized Apneic Adults

Anesthesia Clinical Trial

Official title:

Effect of Head Rotation on Efficiency of Face Mask Ventilation in Anesthetized Apneic Adults: A Prospective Randomized Crossover Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02755077
• Other study ID #: 2013P002571
• Status: Completed
• Phase: N/A
• First received: April 25, 2016
• Last updated: April 26, 2016
• Start date: July 2014
• Est. completion date: January 2016

Study information

• Verified date: April 2016
• Source: Massachusetts General Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

Upper airway obstruction commonly occurs after induction of general anesthesia. The aim of this study is to determine if head rotation improves the efficiency of mask ventilation of anesthetized apneic adults.

Description:

When apnea is achieved after induction, face mask ventilation is started in either a neutral head position or a head position axially rotated 45 degrees to the right. Mask ventilation will be carried out for 1 minute (Step 1) with pressure control ventilation of an anesthesia machine at peak inspiratory pressure 15 cmH2O, 10 breaths per minute, inspiration time to expiration time ratio 1:2 and no positive end-expiratory pressure. Then, mask ventilation will continue but head position will be crossed over (Step 2) and Step 1 will be repeated (Step 3). Expiratory tidal volume (VTE) will be measured by using respiratory inductive plethysmograph.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: January 2016
• Est. primary completion date: January 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

Inclusion Criteria:

• Patients with body mass index in the range of 18.5 to 35.0 kg/m2, who meet American society of anesthesiologists physical status classification I to III and require general anesthesia with tracheal intubation.

Exclusion Criteria:

• Patients with limited head rotation/extension, gastro-esophageal reflux or a full stomach, known sleep apnea in continuous positive airway pressure therapy and any anticipated difficult airway likely requiring awake intubation.

Study Design

Allocation: Randomized, Intervention Model: Crossover Assignment, Masking: Open Label

Related Conditions & MeSH terms

• Anesthesia

Intervention

Procedure:
• Head rotation during mask ventilation
Patient's head position is axially rotated 45 degrees to the right.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Massachusetts General Hospital

References & Publications (3)

Apfelbaum JL, Hagberg CA, Caplan RA, Blitt CD, Connis RT, Nickinovich DG, Hagberg CA, Caplan RA, Benumof JL, Berry FA, Blitt CD, Bode RH, Cheney FW, Connis RT, Guidry OF, Nickinovich DG, Ovassapian A; American Society of Anesthesiologists Task Force on Management of the Difficult Airway. Practice guidelines for management of the difficult airway: an updated report by the American Society of Anesthesiologists Task Force on Management of the Difficult Airway. Anesthesiology. 2013 Feb;118(2):251-70. doi: 10.1097/ALN.0b013e31827773b2. — View Citation

Isono S, Tanaka A, Nishino T. Lateral position decreases collapsibility of the passive pharynx in patients with obstructive sleep apnea. Anesthesiology. 2002 Oct;97(4):780-5. — View Citation

Walsh JH, Maddison KJ, Platt PR, Hillman DR, Eastwood PR. Influence of head extension, flexion, and rotation on collapsibility of the passive upper airway. Sleep. 2008 Oct;31(10):1440-7. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in averaged expiratory tidal volume measured by Respiratory monitor	Change in tidal volume between data of 2 min and average data from 1 and 3 min	1, 2 and 3 min after the initiation of mask ventilation	No